What You Will Do:
Product & Medical Device Security (FDA Regulated Environment):
Secure Software Development Lifecycle (SDLC): Integrate security best practices and tools into every phase of the product development lifecycle from design and requirements to coding testing and deployment.
Threat Modeling & Risk Analysis: Lead and perform threat modeling and security risk analysis (per ISO 14971) for new and existing medical device software.
FDA & Regulatory Compliance: Author review and own all cybersecurity-related documentation for regulatory submissions (e.g. FDA 510(k) pre-market and post-market management plans). Ensure our products and processes align with the latest FDA guidance IEC 62304 and other relevant medical device security standards.
Regulatory Interface: Serve as the primary cybersecurity subject matter expert (SME) for regulatory interactions including responding to questions during FDA submissions and representing the companys cybersecurity posture during audits.
Security Requirements Definition: Partner with Product Management Engineering and Quality teams to define and document security requirements controls and architecture for our medical device platforms.
Vulnerability Management & Penetration Testing: Manage and coordinate third-party penetration testing and internal vulnerability assessments of our products. Develop and oversee the remediation action plan.
Incident Response: Develop implement and maintain an incident response plan for product-related security events including vulnerability disclosure policies.
Corporate Security & Compliance:
Continuous Security Assessment & Strategy: Continuously assess the companys security posture against evolving business needs and emerging threats. Identify relevant security standards (e.g. SOC 2 HIPAA NIST CSF) perform regular gap analyses and own the strategic roadmap for assessment implementation and improvement.
Compliance Frameworks (SOC 2 / HIPAA): Lead the initiative to achieve and maintain SOC 2 certification for our platform and business operations. Develop and manage the security controls and policies required for SOC 2 and HIPAA Security Rule compliance.
Corporate Security Governance: Develop implement and enforce company-wide information security policies procedures and standards.
IT & Cloud Security: Conduct security architecture reviews and risk assessments of our corporate IT and cloud infrastructure (AWS/GCP/Azure). Implement and manage security controls to protect corporate data and systems.
Vendor & Third-Party Risk Management: Establish and manage a program to assess and monitor the security posture of third-party vendors and partners.
Identity & Access Management (IAM): Oversee and improve the companys IAM policies and solutions to ensure the principle of least privilege is maintained.
What You Will Bring:
5 years of experience in cybersecurity with at least 3-5 years in a hands-on senior or lead role.
Proven experience in a regulated industry with a strong preference for MedTech (medical devices) HealthTech or Life Sciences.
FDA Expertise: Demonstrated hands-on experience with FDA cybersecurity guidance for medical devices contributing to the cybersecurity sections of regulatory submissions (e.g. 510(k) PMA) and acting as a subject matter expert in direct interactions with regulatory bodies (e.g. responding to submission questions participating in audits).
Compliance Expertise: Direct experience leading or playing a primary role in achieving and maintaining SOC 2 and/or HIPAA compliance.
Product Security: Strong experience with application security secure SDLC practices threat modeling (e.g. STRIDE) and vulnerability management for software products.
Cloud Security: Deep knowledge of securing cloud environments and services (AWS GCP or Azure).
Technical Skills: Proficiency with security assessment tools IAM systems endpoint protection and network security concepts.
Bachelors degree in Computer Science Information Security or a related field.
Relevant professional certifications are highly desirable (e.g. CISSP CISM HCISPP CSSLP).